Feasibility Trial of a Parent Peer-Co-Led Caregiver Group for Pediatric Early Onset Schizophrenia Spectrum Disorders

NCT07867964 | Not Yet Recruiting

• 1 other identifier: P00054720
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

While early onset schizophrenia spectrum disorders are among the most debilitating psychiatric illnesses, evidence-based treatment for this population is limited. This study evaluates the feasibility and acceptability of a parent peer co-led group intervention for caregivers of youth with Early Onset Schizophrenia Spectrum Disorder to support further refinement. Caregivers of youth with Early Onset Schizophrenia Spectrum Disorder will be invited to participate. Participants will be assigned to either the treatment group or the wait-list control group. Those in the treatment group will receive the group intervention immediately at study start and wait-list participants will be invited to participate following completion of the study. The group intervention consists of 10 group therapy intervention sessions covering psychosis psychoeducation (e.g. symptoms monitoring, stress \& stress management, family communication skills, and coping skills). Feasibility will be assessed through recruitment and retention, acceptability through the Client Satisfaction Questionnaire. Secondary aims include effectiveness using Goal Attainment Scaling (GAS), Perceived Stress Scale (PSS), and qualitative feedback from participants.

Conditions

Schizophrenia; Psychosis

Outcome Measures

Primary Outcomes (2)

• Feasibility measured as attendance to the group sessions

  The average number of total group sessions attended

  Immediately following the last intervention session

• Acceptability as measured on the Client Satisfaction Questionnaire-Participant Versions (CSQ)

  Client Satisfaction Questionnaire-Participant (CSQ) - used to assess acceptability of intervention, as defined by participant ratings on quality of service, fits of the intervention to meet need to support satisfaction, and overall satisfaction.

  Within two weeks following group intervention completion

Secondary Outcomes (2)

• Effectiveness of the intervention as measured on progress on the Goal Attainment Scale (GAS)

  Within two weeks following group intervention completion

• Social Validity

  Post-Intervention

Study Arms (2)

Treatment Group

EXPERIMENTAL

Participants in the Treatment Group will attend 10 group therapy sessions.

Behavioral: Group Therapy

Wait List Control Group

ACTIVE COMPARATOR

Participants in the wait-list control arm will serve as a comparison group for the duration of the primary intervention period. Upon completion of the primary study endpoints and post-tests, the wait-list control group will be offered the opportunity to receive the identical intervention.

Other: Treatment as Usual (TAU)

Interventions

Group Therapy BEHAVIORAL

The intervention consists of 10 sessions. Intervention sessions are held over a secure zoom platform, for 1-1.5 hrs, with up to 10 participants, once/week. The group will be facilitated by licensed psychologist. The group sessions will include, 1) Introductions, Goal Setting, Group Norms, Overview of Group, 2) Psychosis Psychoeducation, 3) Developmental Considerations, 4) Mental Health Systems \& Collaborating with Schools, 5) Role of Stress and Decreasing Stress in the Home, 6) Communication Skills, 7) Health Behaviors, 8) Coping Skills \& The Science of Psychosis, 9) Medications \& Prevention Planning, 10) Goal Setting \& Wrap-Up.

Treatment Group

Treatment as Usual (TAU) OTHER

Participants in the Waitlist group will receive treatment as usual (parent support and guidance from child's clinician, individual therapy for child, and psychopharmacological medication management for their child).

Wait List Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who are 18 years old or older.
• Individuals who are primary caregivers
• Individuals are caregivers of a young person who meets criteria for EOSSD per clinician report.
• Individuals who are fluent in English.

You may not qualify if:

• Non-fluency in English.
• Impaired decision making capacity per PI review.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Brookline, Massachusetts, 02445, United States

Location

Related Publications (14)

• Lee JD, Terol AK, Yoon CD, Meadan H. Parent-to-parent support among parents of children with autism: A review of the literature. Autism. 2024 Feb;28(2):263-275. doi: 10.1177/13623613221146444. Epub 2023 Jan 1.

  PMID: 36588317 BACKGROUND

• Lammers EJ, Zickafoose JS, Peterson GG, Blue L, Stewart KA, Kranker K. Parent Partners: Evaluation of a Novel Peer-Support Intervention for the Caregivers of Children Hospitalized for Behavioral Health Conditions. Acad Pediatr. 2019 Nov-Dec;19(8):908-916. doi: 10.1016/j.acap.2019.06.001. Epub 2019 Jun 6.

  PMID: 31176786 BACKGROUND

• Day C, Michelson D, Thomson S, Penney C, Draper L. Evaluation of a peer led parenting intervention for disruptive behaviour problems in children: community based randomised controlled trial. BMJ. 2012 Mar 13;344:e1107. doi: 10.1136/bmj.e1107.

  PMID: 22416059 BACKGROUND

• Chien WT, Ho LK, Gray R, Bressington D. A randomized controlled trial of a peer-facilitated self-management program for people with recent-onset psychosis. Schizophr Res. 2022 Dec;250:22-30. doi: 10.1016/j.schres.2022.09.028. Epub 2022 Oct 13.

  PMID: 36242787 BACKGROUND

• Castelein S, Bruggeman R, van Busschbach JT, van der Gaag M, Stant AD, Knegtering H, Wiersma D. The effectiveness of peer support groups in psychosis: a randomized controlled trial. Acta Psychiatr Scand. 2008 Jul;118(1):64-72. doi: 10.1111/j.1600-0447.2008.01216.x.

  PMID: 18595176 BACKGROUND

• Rodolico A, Bighelli I, Avanzato C, Concerto C, Cutrufelli P, Mineo L, Schneider-Thoma J, Siafis S, Signorelli MS, Wu H, Wang D, Furukawa TA, Pitschel-Walz G, Aguglia E, Leucht S. Family interventions for relapse prevention in schizophrenia: a systematic review and network meta-analysis. Lancet Psychiatry. 2022 Mar;9(3):211-221. doi: 10.1016/S2215-0366(21)00437-5. Epub 2022 Jan 31.

  PMID: 35093198 BACKGROUND

• Camacho-Gomez M, Castellvi P. Effectiveness of Family Intervention for Preventing Relapse in First-Episode Psychosis Until 24 Months of Follow-up: A Systematic Review With Meta-analysis of Randomized Controlled Trials. Schizophr Bull. 2020 Jan 4;46(1):98-109. doi: 10.1093/schbul/sbz038.

  PMID: 31050757 BACKGROUND

• Calvo A, Moreno M, Ruiz-Sancho A, Rapado-Castro M, Moreno C, Sanchez-Gutierrez T, Arango C, Mayoral M. Psychoeducational Group Intervention for Adolescents With Psychosis and Their Families: A Two-Year Follow-Up. J Am Acad Child Adolesc Psychiatry. 2015 Dec;54(12):984-90. doi: 10.1016/j.jaac.2015.09.018. Epub 2015 Oct 13.

  PMID: 26598473 BACKGROUND

• Fusar-Poli P, McGorry PD, Kane JM. Improving outcomes of first-episode psychosis: an overview. World Psychiatry. 2017 Oct;16(3):251-265. doi: 10.1002/wps.20446.

  PMID: 28941089 BACKGROUND

• Morrison AP, Pyle M, Maughan D, Johns L, Freeman D, Broome MR, Husain N, Fowler D, Hudson J, MacLennan G, Norrie J, Shiers D, Hollis C, James A; MAPS group. Antipsychotic medication versus psychological intervention versus a combination of both in adolescents with first-episode psychosis (MAPS): a multicentre, three-arm, randomised controlled pilot and feasibility study. Lancet Psychiatry. 2020 Sep;7(9):788-800. doi: 10.1016/S2215-0366(20)30248-0. Epub 2020 Jul 7.

  PMID: 32649925 BACKGROUND

• Anagnostopoulou N, Kyriakopoulos M, Alba A. Psychological interventions in psychosis in children and adolescents: a systematic review. Eur Child Adolesc Psychiatry. 2019 Jun;28(6):735-746. doi: 10.1007/s00787-018-1159-3. Epub 2018 May 4.

  PMID: 29728871 BACKGROUND

• McDonagh MS, Dana T, Selph S, Devine EB, Cantor A, Bougatsos C, Blazina I, Grusing S, Fu R, Kopelovich SL, Monroe-DeVita M, Haupt DW. Treatments for Schizophrenia in Adults: A Systematic Review [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2017 Oct. Report No.: 17(18)-EHC031-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK487628/

  PMID: 29537779 BACKGROUND

• Correll CU, Galling B, Pawar A, Krivko A, Bonetto C, Ruggeri M, Craig TJ, Nordentoft M, Srihari VH, Guloksuz S, Hui CLM, Chen EYH, Valencia M, Juarez F, Robinson DG, Schooler NR, Brunette MF, Mueser KT, Rosenheck RA, Marcy P, Addington J, Estroff SE, Robinson J, Penn D, Severe JB, Kane JM. Comparison of Early Intervention Services vs Treatment as Usual for Early-Phase Psychosis: A Systematic Review, Meta-analysis, and Meta-regression. JAMA Psychiatry. 2018 Jun 1;75(6):555-565. doi: 10.1001/jamapsychiatry.2018.0623.

  PMID: 29800949 BACKGROUND

• Kelleher I. Annual Research Review: Psychosis in children and adolescents: key updates from the past 2 decades on psychotic disorders, psychotic experiences, and psychosis risk. J Child Psychol Psychiatry. 2025 Apr;66(4):460-476. doi: 10.1111/jcpp.14088. Epub 2025 Jan 3.

  PMID: 39754377 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Psychotherapy, Group; Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Bernalyn Ruiz-Yu, PhD

  Boston Children's Hospital, Harvard Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernalyn Ruiz-Yu, PhD

CONTACT

617-919-5287; bernalyn.ruiz-yu@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 1, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): May 1, 2027
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)